ObesityNCT00625040
Incretin Physiology and Beta-cell Function Before and After Weight-loss
An observational study of Obesity, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
To evaluate the impact of laparoscopic adjustable gastric banding (LAGB) on beta-cell function, insulin sensitivity, incretin function, postprandial secretion of incretin hormones (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)) in morbidly obese patients and to describe the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Oral glucose tolerance test (OGTT), isoglycemic iv. clamp, liquid meal test, gastric emptying rate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2008to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The cases and controls are recruited from The Bariatric Clinic at Glostrup Hospital
Who may be able to join
- Caucasians without type 2 diabetes mellitus
- Normal OGTT (75 g of glucose) according to WHO's criteria
- Patients fulfilling the criteria for laparoscopic gastric banding
- Normal Hemoglobin
- Informed consent
Who cannot join
- Liver disease (ALAT > 2 x normal level)
- Nephropathy (s-creatinin > 130 µM or albuminuria)
- Relatives (parents/siblings) with T2DM
- Medical treatment witch cannot be stopped for 12 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incretin Physiology and Beta-cell Function Before and After Weight-loss - Effects of Long-term Weight Loss Following Laparoscopic Adjustable Gastric Banding
To evaluate the impact of laparoscopic adjustable gastric banding (LAGB) on beta-cell function, insulin sensitivity, incretin function, postprandial secretion of incretin hormones (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)) in morbidly obese patients and to describe the pathophysiological mechanisms involved in the amelioration of glucose homeostasis during long-term weight loss.
Read the detailed description
Morbid obesity represents a serious health issue in Western countries, with a rising incidence and a strong association with increased mortality and serious co-morbidities, such as diabetes. Surgical interventions, such as laparoscopic gastric banding have been developed with the aim of providing a laparoscopic placed device that is safe and effective in generating substantial weight loss. By investigation of the incretin effect, the secretion of GIP and GLP-1, the insulin response and sensitivity and the beta-cell responsiveness to glucose in 10 obese patients without type 2 diabetes before and after laparoscopic gastric banding the aim of this project is describe the pathophysiological mechanisms involved in the amelioration of glucose homeostasis during long-term weight loss.
- Conditions
- Obesity
- Being tested
- Oral glucose tolerance test (OGTT), isoglycemic iv. clamp, liquid meal test, gastric emptying rate
- Keywords
- Incretin effect, Gastric banding, Glucagon, Glucagon-Like Peptide 1, Gastric Inhibitory Peptide, Glucose Intestinal Peptide, Insulin, C-peptide
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose tolerance test (OGTT), isoglycemic iv. clamp, liquid meal test, gastric emptying rateOther
OGTT: The test is performed with 50 g of glucose deluded in 300 ml water
Isoglycemic iv. clamp: Iv. glucose infusion mimicking the glucose response curves from the OGTT
Liquid Meal test: The test is performed with 100g of formula milk deluded in 300 ml. water
Gastric Emptying Rate: Paracetamol absorption test.
| Study group | Role | What they receive |
|---|---|---|
| A | Obese patients without diabetes with a Body Mass Index > 37 kg/m2 Receives: Other: Oral glucose tolerance test (OGTT), isoglycemic iv. clamp, liquid meal test, gastric emptying rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incretin effect before and one year after gastric banding in obese patients without diabetes
Measured: One year
Secondary outcomes (1)
GLP-1 and GIP response curves
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: Not enough patients in the follow-up period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, European Foundation for the Study of Diabetes, Novo Nordisk A/S
- Responsible party
- Principal investigator, Katrine Bagge Hansen, Glostrup University Hospital, Copenhagen
- Investigators
- Katrine Bagge Hansen, MD, Principal investigator, Glostrup University Hospital, CopenhagenFilip K Knop, MD, PhD, Study director, Gentofte HospitalSteen Larsen, MD, DMSc, Study director, Glostrup University Hospital, CopenhagenJens Juul Holst, MD,DMSc, Study director, University of CopenhagenViggo Kristensen, MD, Study chair, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625040
- Sponsor's protocol ID
- GB-INK
- Status last verified
- Oct 2014
- First submitted
- 19 Feb 2008
- Last updated
- 9 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incretin Physiology and Beta-cell Function Before and After Weight-loss - Effects of Long-term Weight Loss Following Laparoscopic Adjustable Gastric Banding
- ClinicalTrials.gov ID
- NCT00625040
- Acronym / sponsor ID
- GB-INK
- Conditions
- Obesity
- Keywords
- Incretin effect, Gastric banding, Glucagon, Glucagon-Like Peptide 1, Gastric Inhibitory Peptide, Glucose Intestinal Peptide, Insulin, C-peptide
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not enough patients in the follow-up period
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen, European Foundation for the Study of Diabetes, Novo Nordisk A/S
- Study start
- Jan 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 28 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the impact of laparoscopic adjustable gastric banding (LAGB) on beta-cell function, insulin sensitivity, incretin function, postprandial secretion of incretin hormones (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)) in morbidly obese patients and to describe the pathophysiological mechanisms involved in the amelioration of glucose homeostasis during long-term weight loss.
Detailed description
Morbid obesity represents a serious health issue in Western countries, with a rising incidence and a strong association with increased mortality and serious co-morbidities, such as diabetes. Surgical interventions, such as laparoscopic gastric banding have been developed with the aim of providing a laparoscopic placed device that is safe and effective in generating substantial weight loss. By investigation of the incretin effect, the secretion of GIP and GLP-1, the insulin response and sensitivity and the beta-cell responsiveness to glucose in 10 obese patients without type 2 diabetes before and after laparoscopic gastric banding the aim of this project is describe the pathophysiological mechanisms involved in the amelioration of glucose homeostasis during long-term weight loss.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: Oral glucose tolerance test (OGTT), isoglycemic iv. clamp, liquid meal test, gastric emptying rateObese patients without diabetes with a Body Mass Index > 37 kg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cases and controls are recruited from The Bariatric Clinic at Glostrup Hospital
Key inclusion criteria (5 listed)
- Caucasians without type 2 diabetes mellitus
- Normal OGTT (75 g of glucose) according to WHO's criteria
- Patients fulfilling the criteria for laparoscopic gastric banding
- Normal Hemoglobin
- Informed consent
Key exclusion criteria (4 listed)
- Liver disease (ALAT > 2 x normal level)
- Nephropathy (s-creatinin > 130 µM or albuminuria)
- Relatives (parents/siblings) with T2DM
- Medical treatment witch cannot be stopped for 12 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral glucose tolerance test (OGTT), isoglycemic iv. clamp, liquid meal test, gastric emptying rateOGTT: The test is performed with 50 g of glucose deluded in 300 ml water Isoglycemic iv. clamp: Iv. glucose infusion mimicking the glucose response curves from the OGTT Liquid Meal test: The test is performed with 100g of formula milk deluded in 300 ml. water Gastric Emptying Rate: Paracetamol absorption test. | Other | A |
Primary outcome
Incretin effect before and one year after gastric banding in obese patients without diabetes
Time frame: One year
1 secondary outcome
GLP-1 and GIP response curves
Time frame: One year
Results and safety
The study was stopped early (reason given: Not enough patients in the follow-up period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrine Bagge Hansen, MD principal investigator
Glostrup University Hospital, Copenhagen
Filip K Knop, MD, PhD study director
Gentofte Hospital
Steen Larsen, MD, DMSc study director
Glostrup University Hospital, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not enough patients in the follow-up period). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incretin effect before and one year after gastric banding in obese patients without diabetes (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2014.